FDA.reportPublic FDA data

THE CELLIN SUN SCREEN

Manufacturer
Cellinbio Co Ltd | Kolmar Korea Co., Ltd.
Effective date
2014-09-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:40:19

Label at a glance#

ProductTHE CELLIN SUN SCREEN SPF35 PA PLUS PLUS
Active ingredientOctinoxate, Titanium Dioxide, Octisalate
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Octinoxate 7.50%, Titanium Dioxide 5.19%, Octisalate 3.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Water, Cyclopentasiloxane, Glycerin, Dipropylene Glycol, Peg-10 Dimethicone, Hexyl Laurate, Talc, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diste-ardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, Aluminum Stearate, Fragrance, lmidazolidinyl Urea, Methylparaben, Propylparaben, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lavandula Angustifolia(Lavender) Extract, Panax Ginseng Root Extract, Squalane, Iron Oxides(CI77492, CI77491, CI77499), Butylparaben, Methicone

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

DESCRIPTION SECTION

Uses: Helps prevent sunburn

Directions:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months : Ask a doctor

Other information:
Protect this product from excessive heat and direct sun

Questions or comments: 213-325-2780

Shelf Life 3years

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809406892477GTIN-13: 8809406892477
EAN-13: 8809406892477
GTIN storage (14 digits): 08809406892477		the cellin sun screen carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76173-1101-12019-11-27C16284748780-19855e2a2-4776-60a7-e053-dbdaa90a05bd52f7e934-0412-453a-917f-69cc5e932706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76173-1101-1THE CELLIN SUN SCREENSPF35 PA PLUS PLUS75 mL in 1 CARTONCREAM752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76173-1101THE CELLIN SUN SCREEN SPF35 PA PLUS PLUS (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CELLINBIO CO LTD]2Legacy NDC, 1 package rows20140926_52f7e934-0412-453a-917f-69cc5e932706.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OctisalateACTIVE INGREDIENT4X49Y0596W2
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76173-110176173-1101-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Titanium Dioxide15FIX9V2JPACTIB
Octisalate4X49Y0596WACTIB
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cc4a811c-1c63-47a8-80bb-3fd5d02b9c8852f7e934-0412-453a-917f-69cc5e9327062014-09-26WarningsExact identifier
spl id: cc4a811c-1c63-47a8-80bb-3fd5d02b9c88
spl set id: 52f7e934-0412-453a-917f-69cc5e932706

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.